FDA Adverse Event
Malfunction
Summary report: N
VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION KIT
MDR report key: 1013295
·
Received March 12, 2008
Report
- Report Number
- 6000002-2008-06177
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 21, 2008
- Report Date
- February 21, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
REC'D (1) VAMP JR SYSTEM. TUBING WAS COMPLETELY SNAPPED OFF FROM SOLVENT BOND JOINT WITH THE Z-SITE (SAMPLE SITE). THERE SEEMED NO INDICATION OF EXCESSIVE SOLVENT AT THE BOND JOINT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE FAILED DURING PATIENT-SET UP. TUBING BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION KIT | BLOOD SAMPLING KIT | DQO | EDWARDS LIFESCIENCES | VMP306 | 58400722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |